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A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to test if an experimental drug called edaravone is safe and well tolerated in patients with ALS. In this study, you will receive an oral form of edaravone (a liquid solution that you will swallow). This oral formulation is considered experimental, as it has not been approved to treat ALS. The IV (intravenous) form of edaravone has been approved as a treatment for ALS. The IV form was approved in 2017 by the U.S. Food and Drug Administration (“FDA”). It is known by its commercial-brand name, Radicava, and its generic name, edaravone.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Age 18-75
Forced vital capacity ≥ 70% predicted
ALS symptom onset within 3 years
Exclusion Criteria:
Undergoing treatment for cancer
Pregnancy or lactation
Hereditary fructose intolerance
Unable to take medications orally
History of hypersensitivity to edaravone
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Hershey, PA